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A randomized, open-label, multicenter study evaluating the efficacy of peginterferon alfa-2a versus interferon alfa-2a, in combination with ribavirin, in naïve and relapsed chronic hepatitis C patients

Journal Volume 73 - 2010
Issue Fasc.2 - Original articles
Author(s) F. Nevens, H. Van Vlierberghe, F. D'Heygere, J. Delwaide, M. Adler, J. Henrion, A. Lenaerts, A. Hendlisz, P. Michielsen, B. Bastens, R. Brenard, A. Laureys
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(1) Dienst Interne Geneeskunde Hepatologie,UZ Gasthuisberg KULeuven, Leuven ; (2) Dienst Maag- Darm- en Leverziekten, UZ Gent, Ghent ; (3) Dienst Gastro- Enterologie, AZ Groeninge, Kortrijk ; (4) Département de Gastroentérologie, CHU Sart Tilman, Liège ; (5) Service d'Hepato Pancreatologie et de Gastro-Entérologie, Cliniques Universitaires Erasme, Brussels ; (6) Service d'Hepato Gastro-Entérologie, Hôpital de Jolimont, La Louvière ; (7) Service Universitaire de Gastro-Entérologie, CHU Charleroi, Charleroi ; (8) Service de Gastro-Entérologie-Cancerologie, Institut Bordet, Brussels ; (9) Dienst Gastro-Enterologie Hepatologie, UZ Antwerpen, Edegem ; (10) Service d'Hepato Gastro-Entérologie, CHC Liège, Liège ; (11) Service d'Hepato Gastro-Entérologie, Clinique Saint-Joseph, Gilly ; (12) NV Roche SA, Brussels.

Background/Aims : A large multicenter trial to compare the efficacy of peginterferon alfa-2a with interferon alfa-2a, in combi- nation with ribavirin, in chronic hepatitis C patients. Efficacy data for prior relapsers are reported because treatment recommenda- tions for this patient population are not well defined. Patients and methods : This study was a multicenter, prospective, randomized clinical trial. The primary efficacy endpoint was sus- tained virologic response in naïve patients (n = 348) and relapsers (n = 95). Results : Sustained virologic response rates were similar in naïve patients and relapsers, both for non-pegylated and pegylated inter- feron (respectively 27 and 26% and 54 and 43%). Pegylated inter- feron given for 48 weeks did not improved the relapse rate : 15.9 and 27.3% for non-pegylated and 16.7 and 30.4% for pegylated interferon, naïve vs relapsers respectively. Stepwise logistic regres- sion analysis revealed a significant association between slow response (detectable HCV RNA at week 12 and undetectable at week 24) and relapse in patients with an end-of-treatment response (55% versus 13% respectively ; p = 0.02 ; odds ratio = 6.07). Conclusions : This trial confirms the value of using peginter- feron alfa-2a in both naïve and relapsed patients and provides support for a more tailored approach to treatment for relapsers and particulary for patients with a slow viral response. (Acta gastroenterol. belg., 2010, 73, 223-228).

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PMID 20690560